Childhood AnxietyNCT06609824
Learn to Dare! Leiden
A study testing Leer te Durven! in people with Childhood Anxiety and Shyness, run by Leiden University at 1 site in Netherlands.
Trial summary
Research shows that many children face anxiety and stress related problems. However, as much as 70-80% of children do not receive help. The aim of this project is to offer a training for children who are hindered by their shyness or fears, so that all children can develop freely without being held back and so that the… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Anxiety, Shyness
- What is being tested?
- Leer te Durven!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Apr 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Cut-off scores of the SCARED: for girls 31 and for boys 27.
Who cannot join
- Currently under treatment for anxiety complaints or under treatment in the mental health care system for other internalizing complaints.
- Anxiety problems or comorbid problems that require attention or treatment (including a 6 or higher on the severity index (CSR) of the ADIS and a score above the clinical cut-off on the Child Depression Inventory.)
- Difficulty in understanding the training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University
Leiden, South Holland, 2333AK
Anke M Klein, AS, +31655111908, a.m.klein@fsw.leidenuniv.nl
Anika Bexkens, AS, +31715276566, a.bexkens@fsw.leidenuniv.nl
About this study
Research shows that many children face anxiety and stress related problems. However, as much as 70-80% of children do not receive help. The aim of this project is to offer a training for children who are hindered by their shyness or fears, so that all children can develop freely without being held back and so that the risk of escalation of fear and stress in the long term can be prevented. In this project the prevention training 'Learn to Dare!' will be offered to children between the ages of 8 and 18 where the long-term outcomes and the program itself will be evaluated for attractiveness and satisfaction. With the evidence-based program 'Learn to Dare!\' children between the ages of 8 and 12 learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. This project aims to adapt the program so that it can be available up to and including 18 years in the future.
Read the detailed description
Participants are recruited via the 'Knowledge Centre Anxiety and Stress in youth' (KAS) telephone line, by a research assistant or via the waiting list of LUBEC. Following recruitment, a research assistant conducts a screening call with the parent(s) lasting approximately half an hour to determine the child\'s eligibility for the project. Subsequently, the research assistant collaborates with a therapist from KAS/LUBEC to evaluate the case. If both agree that the child meets the criteria of the \'Learn to Dare!\' program, the research assistant proceeds to conduct a diagnostic interview with both the child and parents. When the child still meets the requirements for \'Learn to Dare!\', the therapist from LUBEC, who is going to give the trainings, will do an intake with the child and parents.
When the child still meets the criteria after this intake, a subsequent appointment will take place at LUBEC in Leiden, that serves as an opportunity for parents and children to familiarize themselves with the therapist and complete the baseline 1 measurement. This appointment will take about 1,5-2 hours. Two research assistants will administer questionnaires to the parent(s) and the child: demographics questionnaire, SCARED, CDI, WIRK-ALL. In addition, they will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parent(s) and the child.
After baseline 1, there will be a waiting period of 4 weeks. After this period, the child and parents complete the SCARED questionnaire online (30 minutes) before commencing the treatment phase. The treatment comprises eight group sessions of \'Learn to Dare!\' (one session per week; 1.5 hours each) along with assigned homework. After those eight weeks of treatment, the post-treatment session will take place at LUBEC (1,5-2 hours). The therapist will meet with the child and the parent(s) to evaluate the treatment together. The research assistants will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parent(s) and the child. In addition, a couple of questionnaires will be administered: SCARED, CDI, WIRK-ALL, Training Evaluation Questionnaire. Lastly, there will be three follow-ups 6, 12, and 24 months after treatment (1,5 hours per follow-up). Parents have the option to conduct these follow-ups either at LUBEC or online. The anxiety scale of the SCID, along with the severity index of the ADIS questionnaire, is administered, along with supplementary questionnaires: SCARED, CDI, WIRK-ALL.
- Conditions
- Childhood Anxiety, Shyness
- Being tested
- Leer te Durven!
- Keywords
- Prevention, Childhood Anxiety, Shyness
- Medical subject headings
- Shyness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leer te Durven!Behavioural
'Leer te Durven!' is an eight-week preventative group training for children between the ages of 8 and 12. This training is evidence-based and is based on the principles of Cognitive Behavioral Therapy. With this program children learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. The training consists, among other things, of psychoeducation, exposure, and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | This arm consists of all participants who receive the training intervention. The purpose is to assess longitudinal effectiveness of the training within all participants. Receives: Behavioral: Leer te Durven! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety severity in children (SCARED-child)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the children. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Measured: During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)
Change in anxiety severity in children (SCARED-parent)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the parents. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Measured: During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)
Change in severity of anxiety in children (SCID-parent)
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the parents.
Measured: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Change in severity of anxiety in children (SCID-child)
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the children.
Measured: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Secondary outcomes (1)
Change in self-efficacy of the children (WIRK-ALL child version)
The WIRK-all will be administered to the children to assess their change in self-efficacy. The WIRK-ALL is a short questionnaire and is an adaptation of the General Self-Efficacy Scale. The scores on the WIRK-ALL range between 10 and 40, with higher scores indicating higher self-efficacy.
Measured: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start2 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- Leids Universitair Behandel en Expertise Centrum (LUBEC)
- Responsible party
- Principal investigator, Anke M Klein, AS, Leiden University
- Investigators
- Anke M Klein, AS, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609824
- Sponsor's protocol ID
- 2024-02-27-A.M. Klein-V2-5116
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share the data upon request, but only for specific purposes. In addition, the data needs to be deleted after use. The investigators will not share data that cannot be anonymised, such as the video data.
Publications
Simon E, de Hullu E, Bogels S, Verboon P, Butler P, van Groeninge W, Slot W, Craske M, Whiteside S, van Lankveld J. Development of 'learn to dare!': An online assessment and intervention platform for anxious children. BMC Psychiatry. 2020 Feb 11;20(1):60. doi: 10.1186/s12888-020-2462-3.
PubMed 32046669
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learn to Dare! Leiden
- ClinicalTrials.gov ID
- NCT06609824
- Acronym / sponsor ID
- 2024-02-27-A.M. Klein-V2-5116
- Conditions
- Childhood Anxiety, Shyness
- Keywords
- Prevention, Childhood Anxiety, Shyness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- Leids Universitair Behandel en Expertise Centrum (LUBEC)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that many children face anxiety and stress related problems. However, as much as 70-80% of children do not receive help. The aim of this project is to offer a training for children who are hindered by their shyness or fears, so that all children can develop freely without being held back and so that the risk of escalation of fear and stress in the long term can be prevented. In this project the prevention training 'Learn to Dare!' will be offered to children between the ages of 8 and 18 where the long-term outcomes and the program itself will be evaluated for attractiveness and satisfaction. With the evidence-based program 'Learn to Dare!\' children between the ages of 8 and 12 learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. This project aims to adapt the program so that it can be available up to and including 18 years in the future.
Detailed description
Participants are recruited via the 'Knowledge Centre Anxiety and Stress in youth' (KAS) telephone line, by a research assistant or via the waiting list of LUBEC. Following recruitment, a research assistant conducts a screening call with the parent(s) lasting approximately half an hour to determine the child\'s eligibility for the project. Subsequently, the research assistant collaborates with a therapist from KAS/LUBEC to evaluate the case. If both agree that the child meets the criteria of the \'Learn to Dare!\' program, the research assistant proceeds to conduct a diagnostic interview with both the child and parents. When the child still meets the requirements for \'Learn to Dare!\', the therapist from LUBEC, who is going to give the trainings, will do an intake with the child and parents.
When the child still meets the criteria after this intake, a subsequent appointment will take place at LUBEC in Leiden, that serves as an opportunity for parents and children to familiarize themselves with the therapist and complete the baseline 1 measurement. This appointment will take about 1,5-2 hours. Two research assistants will administer questionnaires to the parent(s) and the child: demographics questionnaire, SCARED, CDI, WIRK-ALL. In addition, they will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parent(s) and the child.
After baseline 1, there will be a waiting period of 4 weeks. After this period, the child and parents complete the SCARED questionnaire online (30 minutes) before commencing the treatment phase. The treatment comprises eight group sessions of \'Learn to Dare!\' (one session per week; 1.5 hours each) along with assigned homework. After those eight weeks of treatment, the post-treatment session will take place at LUBEC (1,5-2 hours). The therapist will meet with the child and the parent(s) to evaluate the treatment together. The research assistants will administer the anxiety scale of the SCID in combination with the ADIS severity index to the parent(s) and the child. In addition, a couple of questionnaires will be administered: SCARED, CDI, WIRK-ALL, Training Evaluation Questionnaire. Lastly, there will be three follow-ups 6, 12, and 24 months after treatment (1,5 hours per follow-up). Parents have the option to conduct these follow-ups either at LUBEC or online. The anxiety scale of the SCID, along with the severity index of the ADIS questionnaire, is administered, along with supplementary questionnaires: SCARED, CDI, WIRK-ALL.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Leer te Durven!This arm consists of all participants who receive the training intervention. The purpose is to assess longitudinal effectiveness of the training within all participants. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Cut-off scores of the SCARED: for girls 31 and for boys 27.
Key exclusion criteria (3 listed)
- Currently under treatment for anxiety complaints or under treatment in the mental health care system for other internalizing complaints.
- Anxiety problems or comorbid problems that require attention or treatment (including a 6 or higher on the severity index (CSR) of the ADIS and a score above the clinical cut-off on the Child Depression Inventory.)
- Difficulty in understanding the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leer te Durven!'Leer te Durven!' is an eight-week preventative group training for children between the ages of 8 and 12. This training is evidence-based and is based on the principles of Cognitive Behavioral Therapy. With this program children learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. The training consists, among other things, of psychoeducation, exposure, and relaxation. | Behavioural | Training Group |
Primary outcome
Change in anxiety severity in children (SCARED-child)
Time frame: During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the children. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Change in anxiety severity in children (SCARED-parent)
Time frame: During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)
The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the parents. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.
Change in severity of anxiety in children (SCID-parent)
Time frame: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the parents.
Change in severity of anxiety in children (SCID-child)
Time frame: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the children.
1 secondary outcome
Change in self-efficacy of the children (WIRK-ALL child version)
Time frame: From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 32046669Simon E, de Hullu E, Bogels S, Verboon P, Butler P, van Groeninge W, Slot W, Craske M, Whiteside S, van Lankveld J. Development of 'learn to dare!': An online assessment and intervention platform for anxious children. BMC Psychiatry. 2020 Feb 11;20(1):60. doi: 10.1186/s12888-020-2462-3.
- Individual participant dataSharing planned: No. The investigators will share the data upon request, but only for specific purposes. In addition, the data needs to be deleted after use. The investigators will not share data that cannot be anonymised, such as the video data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anke M Klein, AS principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leer te Durven! in people with Childhood Anxiety and Shyness, run by Leiden University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anke M Klein, AS (+31655111908, a.m.klein@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety severity in children (SCARED-child) (time frame: During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06609824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.